UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 25, 2020
Zynex, Inc.
(Exact Name of Registrant as Specified in its Charter)
| Nevada | 001-38804 | 90-0275169 | ||
| (State or other jurisdiction of incorporation) |
Commission File Number |
(I.R.S. Employer Identification number) |
9555 Maroon Circle, Englewood, CO 80112
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (303) 703-4906
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Securities registered pursuant to Section 12(b) of the Act: | ||
| Title of each class | Ticker symbol(s) | Name of each exchange on which registered |
| Common Stock, $0.001 par value per share | ZYXI | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
| ITEM 7.01 | Regulation FD Disclosure |
On February 25, 2020, Zynex, Inc. issued a press release announcing the U.S. Food and Drug Administration (“FDA”) granted 510(k) clearance for sale in the U.S. of the Company’s CM-1500 Blood Volume Monitor. A copy of the press release is furnished herewith as Exhibit 99.1.
The information disclosed under this Item 7.01, including Exhibit 99.1 hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth in such filing.
| ITEM 9.01 | FINANCIAL STATEMENTS AND EXHIBITS |
d) Exhibits. The following exhibits are filed with this report.
| Exhibit No. | Description | |
| 99.1 | Zynex, Inc. Press Release dated February 25, 2020 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Zynex, Inc. | |||
| Date: | February 25, 2020 | By: | /s/ Daniel Moorhead |
| Daniel Moorhead | |||
| Chief Financial Officer |
Exhibit 99.1
Zynex Receives FDA Clearance for its Blood Volume Monitor
ENGLEWOOD, CO – February 25, 2020 – Zynex, Inc. (NASDAQ: ZYXI), an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, stroke rehabilitation, cardiac monitoring and neurological diagnostics, today announced the U.S. Food and Drug Administration (“FDA”) granted 510(k) clearance for sale in the U.S. for the CM-1500 Blood Volume Monitor.
Thomas Sandgaard, CEO said: “I am very excited to finally have obtained FDA clearance to sell our non-invasive Blood Volume Monitor in the U.S. The device is fully developed, has performed well in multiple clinical trials and can guide medical professionals in hospitals and surgical centers towards better fluid management during surgery and in recovery settings. Fluid management during and after surgery is one of the largest un-met needs in hospitals today.”
About Zynex,
Inc.
Zynex, founded in 1996, markets and sells its own design of electrotherapy medical devices
used for pain management and rehabilitation; and the company's proprietary NeuroMove device designed to help recovery of stroke
and spinal cord injury patients. Zynex is also developing a new blood volume monitor for use in hospitals and surgery centers.
For additional information, please visit: www.zynex.com.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those that express plans, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact.
In some cases, you can identify forward-looking statements by terminology, such as “expects,” “anticipates,” “intends,” “estimates,” “plans,” “believes,” “seeks,” “may,” “should,” “could,” “will,” “future,” “projects,” “strategy,” or the negative of such terms or other similar expressions.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results to materially differ from forward-looking statements include, but are not limited to, the need to obtain FDA clearance and CE marking of new products, the acceptance of new products as well as existing products by doctors and hospitals, larger competitors with greater financial resources, the need to keep pace with technological changes, our dependence on the reimbursement for our products from health insurance companies, our dependence on third party manufacturers to produce our goods on time and to our specifications, implementation of our sales strategy including a strong direct sales force and other risks described in our filings with the Securities and Exchange Commission including the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2018.
Any forward-looking statement made by us in this release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Contact: Zynex, Inc. (303) 703-4906
Investor
Relations Contact:
Amato And Partners, LLC
Investor Relations Counsel
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